Donor Lymphocytes to Prevent Graft-Versus-Host Disease in Patients With Chronic Myeloid Leukemia

NCT00004878 | Withdrawn Phase 2

• 4 other identifiers: CDR0000067538UCLA-9905097CCT-C99-101NCI-G00-1672
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Sometimes the transplanted cells can be rejected by the body's normal tissues. Donor lymphocytes that have been treated in the laboratory may prevent this from happening. PURPOSE: Randomized phase II trial to study the effectiveness of donor lymphocytes to prevent graft-versus-host disease in patients who are undergoing peripheral stem cell transplantation for chronic myeloid leukemia.

Conditions

Graft Versus Host Disease; Leukemia

Keywords

chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; Philadelphia chromosome positive chronic myelogenous leukemia; graft versus host disease

Interventions

therapeutic allogeneic lymphocytes BIOLOGICAL

cytarabine DRUG

fludarabine phosphate DRUG

idarubicin DRUG

methotrexate DRUG

tacrolimus DRUG

in vitro-treated peripheral blood stem cell transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven chronic myeloid leukemia (CML) in first chronic phase or with cytogenetic but not hematologic evidence of acceleration (clonal evolution) Availability of 6 antigen (A, B, and DR loci) HLA identical sibling donor Eligible for randomization to donor lymphocyte infusion (DLI) if: Residual Ph+ cells by cytogenetics or FISH or hematologic or clinical evidence of CML AND No graft versus host disease requiring immunosuppressive therapy within the past 2 weeks AND Evidence of donor hematopoiesis after completion of transplantation Ineligible for randomization to DLI if: Blast transformation of CML OR Prior interferon alfa for relapse after completion of transplantation PATIENT CHARACTERISTICS: Age: 50 to 70 Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 3 mg/dL Renal: Creatinine less than 2 mg/dL Cardiovascular: Cardiac ejection fraction greater than 40% Pulmonary: DLCO greater than 45% predicted Other: No active infection Not pregnant Negative pregnancy test No hypersensitivity to nickel No hypersensitivity to mouse proteins Human antimouse antibody positivity allowed if no allergic history HIV negative HTLV antibody negative PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent hematopoietic growth factors other than filgrastim (G-CSF) No other biologic therapy (e.g., interferon alfa) for 6 months after completion of study therapy Chemotherapy: No other chemotherapy for 6 months after completion of study therapy Concurrent hydroxyurea allowed for CML relapse Endocrine therapy: Concurrent methylprednisolone allowed if grade II or worse GVHD develops Radiotherapy: No radiotherapy for 6 months after completion of study therapy Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Graft vs Host Disease; Leukemia; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Cytarabine; fludarabine phosphate; Idarubicin; Methotrexate; Tacrolimus; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Macrolides; Lactones; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Gary J. Schiller, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: April 28, 2004
• Last Updated: July 31, 2020

Record last verified: 2012-07